Carisoprodol 350 mg/1
Carisoprodol · TABLET · Wilshire Pharmaceuticals, Inc.
Carisoprodol is a muscle relaxant taken by mouth as a tablet that helps relieve discomfort from muscle injuries and spasms. It is typically used along with rest and physical therapy as part of a treatment plan for acute musculoskeletal conditions.
Key Facts
- Brand Name
- Carisoprodol
- Generic Name
- Carisoprodol
- NDC Code (Product)
52536-688- Manufacturer
- Wilshire Pharmaceuticals, Inc.
- Strength
- 350 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA205126
- Drug Class
- Muscle Relaxant [EPC]
- Marketing Start
- 02/15/2017
Recall History
West-Ward Pharmaceutical Corp.
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Watson Laboratories Inc
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurity/degradation Specification
West-ward Pharmaceutical Corp.
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
Physicians Total Care, Inc.
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
West-ward Pharmaceutical Corp.
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use Carisoprodol should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [ see Dosage and Administration (2) ]. Carisoprodol is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1) Limitations of Use Should only be used for acute treatment periods up to two or three weeks ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of carisoprodol is 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol use is up to two or three weeks. Recommended dose is 350 mg three times a day and at bedtime. (2)
Contraindications
4 CONTRAINDICATIONS Carisoprodol is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate. Acute intermittent porphyria (4) Hypersensitivity reactions to a carbamate such as meprobamate (4)
Drug Interactions
7 DRUG INTERACTIONS CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects ( 5.1 , 7.1 ) 7.1 CNS Depressants The sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended [ see Warnings and Precautions (5.1) ]. 7.2 CYP2C19 Inhibitors and Inducers Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate [ see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with carisoprodol could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John’s Wort, with carisoprodol could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alt…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Oxford Pharmaceuticals LLC at 1-844 508 1455 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [ see Clinical Studies (14) ]. In these studies, patients were treated with 250 mg of carisoprodol, 350 mg of carisoprodol, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other. There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treate…
Frequently Asked Questions
What is Carisoprodol used for?
Carisoprodol is a muscle relaxant taken by mouth as a tablet that helps relieve discomfort from muscle injuries and spasms. It is typically used along with rest and physical therapy as part of a treatment plan for acute musculoskeletal conditions.
Is Carisoprodol a controlled substance?
Yes, Carisoprodol is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Carisoprodol?
The generic name for Carisoprodol is Carisoprodol. There are 5 other brand versions of Carisoprodol.
What is the NDC code for Carisoprodol 350 mg/1?
The NDC (National Drug Code) for Carisoprodol 350 mg/1 is 52536-688, listed by Wilshire Pharmaceuticals, Inc..